Meloy Laboratories, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Meloy Laboratories, Inc.” (first 1977, latest 1985), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 37 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 5 | 5 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CJQ | Radial Immunodiffusion, Albumin | 1 | 1 |
| DBE | Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 | 1 |
Plus 1 more product codes.
Review panels
- Immunology (8)
- Clinical Chemistry (4)
- Hematology (1)
Most recent Meloy Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852033 | SS-A(RO) & SS-B(LA) ANTIBODY ASSAY | DHN | 1985-06-21 | 43 |
| K844678 | MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL | DHN | 1985-01-04 | 35 |
| K841708 | MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII | GGP | 1984-07-19 | 87 |
| K842247 | MELOY AUTOANTIBODY TEST SYS | DBM | 1984-06-26 | 20 |
| K831292 | ANTI-ENA TEST | LKO | 1983-07-18 | 89 |
| K820265 | ANA TEST (MOUSE LIVER SUBSTRATE) | DHN | 1982-02-12 | 10 |
| K820005 | TOTAL HEMOLYTIC COMPLEMENT TEST KIT | — | 1982-01-22 | 18 |
| K811178 | HUMAN IGG-ALBUMIN TEST KIT | CJQ | 1981-05-15 | 17 |
| K792562 | IMMUNOSTAT TSH TEST | JLW | 1980-01-16 | 35 |
| K791493 | ANTI-NUCLEAR ANTIBODY TEST | DHN | 1979-09-24 | 53 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Meloy Laboratories, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Meloy Laboratories, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Meloy Laboratories, Inc.” (first 1977, latest 1985), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Meloy Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meloy Laboratories, Inc. is 37 days.
Which FDA product codes appear under Meloy Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, 5); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 2); CDX (Radioimmunoassay, Total Thyroxine, 1).
Next steps
- See all 15 Meloy Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DHN, Meloy Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.